| CTRI Number |
CTRI/2025/09/095275 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study efficacy of triphla churna with musta churna in the management of obesity |
|
Scientific Title of Study
|
Randomised controlled clinical study on the efficacy of triphla churna with musta churna in the management of medoroga with special reference to childhood obesity. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnkant Ravindra Gaikwad |
| Designation |
MD Scholar Kaumarbhritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadpsar Pune pune |
| Address |
MAM S Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadpsar Pune OPD NO 13 Department of Kaumarbhritya Sane Guruji Aarogya Kendra Malwadi Hadpsar Pune
Maharashtra
411028
India
More Galli ,Tanaji Chowk,Ausa taluka Ausa district Latur
Pune
MAHARASHTRA
411028
India |
| Phone |
9284659910 |
| Fax |
|
| Email |
kgaikwad543@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Ramchandra Waghmare |
| Designation |
Professor of Department of Kaumarbhritya |
| Affiliation |
Sane Guruji Aarogya Kendra Pune |
| Address |
Department of Kaumarbhritya Ground floor Room no 13 Kaumarbhritya division MAM S Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadpsar
Pune
Maharashtra
411028
India
Department of Pediatrics 3rd floor Room no 409 Division of Pediatrics infront of Boys hostel Sane Guruji Aarogya Kendra Malwadi Hadpsar Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9320383834 |
| Fax |
|
| Email |
drnitinwaghmare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Ramchandra Waghmare |
| Designation |
Professor of Department of Kaumarbhritya |
| Affiliation |
Sane Guruji Aarogya Kendra Pune |
| Address |
Department of Kaumarbhritya Ground Floor Room no 13 Division of Kaumarbhritya MAM S Sumatibhai Shah Ayurveda Mahavidyalaya Malwadi Hadpsar Pune
Maharashtra
411028
India
Department of Pediatrics 3rd floor Room no 409 Division of Pediatrics infront of Boys hostel Sane Guruji Aarogya Kendra Malwadi Hadpsar Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9320383834 |
| Fax |
|
| Email |
drnitinwaghmare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Triphla Churna and Musta Churna with Honey will be given to Patients with proper Dose in the form of Churna |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Aarogya Kendra |
| Address |
Sane Guruji Aarogya Kendra Malwadi Hadpsar Pune 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr KRISHNKANT GAIKWAD |
SANE GURUJI AAROGYA KENDRA HOSPITAL HADPSAR PUNE |
Department of Kaumarbhritya Opd no 13 pediatrics division Ground floor Sumatibhai shah ayurved mahavidyalaya Malwadi HADPSAR PUNE
Pune
MAHARASHTRA |
9284659910
kgaikwad543@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphla churna , Reference: Sharanghdhar samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Dose of triphla churna is according to age of child
10 year 2.7 gm
11 year 2.8 gm
12 year 3 gm
13 year 3.1 gm
14 year 3.2 gm | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Musta churna , Reference: Charak samhita sutrasthan , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Dose of musta churna is according to age of children
10 year 2.7 gms
11 year 2.8 gms
12 year 3 gms
13 year 3.1 gms
14 year 3.2 gms |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of 10-14 years age group will be selected Irrespective of gender caste religion with following criteria BMI greater than or equal to 85th percentile for age and sex A child having pendulous appearance of sphika udar stan A child having cardinal symptoms of Atisthauholya |
|
| ExclusionCriteria |
| Details |
Concurrent participation in another trail or study,known allergies or adverse reactions to any component of triphla churna,children below 10 years of age and above 15 years age, children with secondary causes of obesity like hypothyroidism,cushings syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of triphala churna in reducing body weight in children diagnosed with childhood obesity
To assess the efficacy of musta churna in reducing body weight of children |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the clinical effectiveness of triphla churna on body mass index waist circumference
To monitor & assess safety & tolerability of triphla churna
To document any adverse effects of triphla churna like loose motions vomiting nausea
To study whether the triphla churna is habit forming |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is the randomised controlled study to evaluate the efficacy of triphla churna and musta churna in the management of Atisthauholya in the children of age group 10 to 14 years for 30 days Primary objective is to compare the efficacy of triphla churna and musta churna in the management of Atisthauholya In children of age group 10 to 14 years for 30 days Assessment of patient will be done on the basis of assessment criteria based on subjective and objective criteria Follow up and assessment will be on 1st 7 th 14 th 28 th day |